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venlafaxine hydrochloride, extended release

Prescription ANDA TE AB
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
venlafaxine hydrochloride, extended release
Generic name
venlafaxine hydrochloride, extended release
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Edenbridge Pharmaceuticals LLC.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Venlafaxine Hydrochloride 150 mg/1 808744 View
Venlafaxine Hydrochloride 225 mg/1 808744 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Norepinephrine Uptake Inhibitors [MoA] MoA All 44 members
Serotonin Uptake Inhibitors [MoA] MoA All 73 members
Serotonin and Norepinephrine Reuptake Inhibitor [EPC] EPC All 26 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
209193
Application type
ANDA · Abbreviated New Drug Application
Approval date
October 31, 2019
Sponsor
DEXCEL
Products on application
2
Submissions recorded
3
Products approved under application 209193.
Product Trade name Form Strength Ingredient Status TE Flags
209193-001 VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE VENLAFAXINE HYDROCHLORIDE Prescription AB
209193-002 VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE VENLAFAXINE HYDROCHLORIDE Prescription AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 209193.
Type No. Action Status Date Review
Supplement 5 Labeling Approved November 21, 2023 Standard
Supplement 3 Labeling Approved August 9, 2022 Standard
Original application 1 Approved October 31, 2019 Standard

Adverse event reports

Source: openFDA FAERS
131,566
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: VENLAFAXINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
42799-962-01 42799-962 Edenbridge Pharmaceuticals LLC. 30 TABLET in 1 BOTTLE (42799-962-01) March 15, 2023
42799-962-02 42799-962 Edenbridge Pharmaceuticals LLC. 90 TABLET in 1 BOTTLE (42799-962-02) March 15, 2023
42799-963-01 42799-963 Edenbridge Pharmaceuticals LLC. 30 TABLET in 1 BOTTLE (42799-963-01) March 15, 2023
42799-963-02 42799-963 Edenbridge Pharmaceuticals LLC. 90 TABLET in 1 BOTTLE (42799-963-02) March 15, 2023
42799-962 42799-962 Edenbridge Pharmaceuticals LLC. — March 15, 2023
42799-963 42799-963 Edenbridge Pharmaceuticals LLC. — March 15, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.